WA21092-Phase III Ocrelizumab Vs Rebif in Relapsing Multiple Sclerosis

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis

• IRAS ID

  64183

• Contact name

  Mike Boggild

• Sponsor organisation

  Roche Products Ltd

• Eudract number

  2010-020337-99

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  WA21092 is a Phase III Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif©) In patients With Relapsing Multiple Sclerosis (MS). The purpose of this study is to assess whether the efficacy of ocrelizumab 600 mg (given as dual infusions of 300 mg on days 1 and 15 of the 1st 24 weeks treatment and as a single 600 mg infusion on Day 1 of the following treatment cycles) given intravenously every 24 weeks is superior to Rebif© as measured by the annualized protocol-defined relapse rate at two years (96 weeks) in patients with relapsing MS. Protocol-defined relapse is the occurrence of new or worsening neurological symptoms attributable to MS. Symptoms must persist for more than 24 hours and should not be attributable to confounding clinical factors (e.g. fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for at least 30 days. The new or worsening neurological symptoms must be accompanied by objective neurological worsening consistent with an increase of at least half a step on the EDSS (Expanded Disability Status Scale) scale, or 2 points on one of the appropriate FSS (Functional Systems Scores), or 1 point on two or more of the appropriate FSS. The change must affect the selected FSS (i.e., pyramidal, ambulation, cerebellar, brainstem, sensory, or visual). Episodic spasms, sexual dysfunction, fatigue, mood change, or bladder or bowel urgency or incontinence will not be sufficient to establish a relapse. Sexual dysfunction and Fatigue will not be scored.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  11/NW/0490

• Date of REC Opinion

  20 Oct 2011

• REC opinion

  Further Information Favourable Opinion